FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
30337–30360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2016
SpiroScout
K160116 · BZG
Ganshorn Medizin Electronic GmbH
Anesthesiology · 262d
Cleared Oct 07, 2016
EnSite Velocity Surface Electrode Kit
K160186 · DQK
St Jude Medical
Cardiovascular · 254d
Cleared Oct 07, 2016
Cryotop Vitrification Kit and Cryotop Thawing Kit
K160864 · MQL
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 192d
Cleared Oct 07, 2016
Sterilization Tray
K160912 · KCT
STERIS Corporation
General Hospital · 189d
Cleared Oct 07, 2016
Pantera Pro
K160985 · LOX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Oct 07, 2016
PK Morcellator
K161038 · GEI
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 177d
Cleared Oct 07, 2016
Turbo-Flo PICC Sets
K161496 · LJS
Cook Incorporated
General Hospital · 128d
Cleared Oct 07, 2016
CAVUX™ Cervical Cage
K161642 · ODP
Providence Medical Technology, Inc.
Orthopedic · 115d
Cleared Oct 07, 2016
Straumann Sterile Healing Solution
K161677 · NHA
Institut Straumann AG
Dental · 112d
Cleared Oct 07, 2016
Pyrenees Cervical Plate System
K162664 · KWQ
K2m, Inc.
Orthopedic · 11d
Cleared Oct 06, 2016
I.B.S. 2.0 Osteosynthesis screw
K160174 · HWC
In2bones Sas
Orthopedic · 253d
Cleared Oct 06, 2016
uVue HSG/SHG Catheter
K160217 · LKF
Cook Incorporated
Obstetrics & Gynecology · 251d
Cleared Oct 06, 2016
SimulCare II(TM)
K160246 · GZJ
Xanacare Technologies, LLC
Neurology · 248d
Cleared Oct 06, 2016
iSR'obot MRI-US Fusion
K161109 · LLZ
Biobot Surgical Pte., Ltd.
Radiology · 169d
Cleared Oct 06, 2016
Pour Acrylic
K161330 · EBI
Dentsply Sirona
Dental · 147d
Cleared Oct 06, 2016
HydroSet XT
K161447 · MQV
Orthovita, Inc.
Orthopedic · 134d
Cleared Oct 06, 2016
MR Syringe Dual Pack for Solaris Injectors
K161471 · DXT
Coeur, Inc.
Cardiovascular · 132d
Cleared Oct 06, 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 120d
Cleared Oct 06, 2016
Quantum LB
K161684 · DYH
Reliance Orthodontic Products, Inc.
Dental · 111d
Cleared Oct 06, 2016
CuattroDR
K161937 · KPR
Cuattro, LLC
Radiology · 84d
Cleared Oct 06, 2016
Ziehm Solo FD
K161976 · OWB
Ziehm Imaging GmbH
Radiology · 80d
Cleared Oct 06, 2016
Sapphire NC Plus
K162209 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 62d
Cleared Oct 06, 2016
1012WCC, 1012WGC
K162518 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Oct 06, 2016
1717WCC / 1717WGC
K162519 · MQB
Rayence Co., Ltd.
Radiology · 27d